Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Set, Transfer (Blood/Plasma)
510(k) Number K001043
Device Name KAWASUMI LABORATORY BLOOD DRAWING KIT
Applicant
KAWASUMI LABORATORIES AMERICA, INC.
5905 C HAMPTON OAKS PKWY.
TAMPA,  FL  33610
Applicant Contact JACK PAVLO
Correspondent
KAWASUMI LABORATORIES AMERICA, INC.
5905 C HAMPTON OAKS PKWY.
TAMPA,  FL  33610
Correspondent Contact JACK PAVLO
Regulation Number864.9875
Classification Product Code
KSB  
Subsequent Product Code
LHI  
Date Received03/31/2000
Decision Date 05/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-